Compulsory Licensing Controversy In Thailand
Background
Between November 2006 and January 2007, Thailand's Ministry of Health granted licenses for patents on two antiretroviral drugs (efavirenz and lopinavir+ritonavir) and clopidogrel, a heart medication sold by Bristol Myers Squibb. The licenses were issued for government use, after years of prior negotiation with the patent holders, and include a 0.5% royalty rate.
Abbott responded to the compulsory license for lopinavir+ritonavir, which it sells under the brand name Kaletra, by announcing it would no longer register new drugs for sale in Thailand. The US Trade Representative placed Thailand on its 301 Priority Watch List, citing "further indications of a weakening of respect for patents, as the Thai Government announced decisions to issue compulsory licenses for several patented pharmaceutical products."
In February 2008, the new Thai Minister of Public Health Chaiya Sasomsab announced that he was reviewing the compulsory licenses that have been issued, as well as four more proposed compulsory licenses for cancer medications. This happened amid growing pressure against Thailand from the US pharmaceutical industry, which let it be known it is lobbying the US government to effectively raise tariffs on Thailand's exports by removing the nation's GSP benefits. In March the Minister recommended that the compulsory licenses remain in place, but the licenses could still be revoked by the Minister of Commerce.
In February 2009, the US drug industry recommended that Thailand be included in the USTR's Special 301 Report as a Priority Foreign Country, a designation more serious than incluaion on the Priority Watch List. On February 23, the Commerce Ministry sent a lietter to the Public Health Ministry's permanent secretary asking that no more licenses be issued for essential drugs.
March 2009 Developments Reported by the Thai Press
- Theerawut Sathitphattarakul and Phusadee Arunmas. Cheap Drug Cap Raises Outcry: US Accused of Exerting Unfair Trade Leverage. (March 4, 2009).
- AFP Bangkok. Thai AIDS Activists Urge More Generic Drugs. (March 4, 2009).
PIJIP Documents
- Timeline of US-Thailand Compulsory Licensing Dispute. (April 2, 2009),
- Sean Flynn, Appeal of Thailand Commission Order on Abbott's Refusal to Sell AIDS Medications in Thailand. (January 17, 2008).
- Sean Flynn and Mike Palmedo. The Price of Kaletra in Thailand. (April 30, 2007).
- Sean Flynn. Thailand's Lawful Compulsory Licenses and Abbott's Anticompetitive Response, (April 26, 2007).
- American University. PIJIP Releases Report on Lawful Thai Licenses and Abbott's Anticompetitive Response, (April 26, 2007).
- Sean Flynn, Brook Baker, Judit Rius Sanjuan and Robert Weissman. World's "Premiere" Law Firm Goes to Bat for Abbott: Specious Arguments on Thailand's Compulsory Licenses. Bangkok Post, (April 23, 2007)
- Sean Flynn. Considering Competition Complaints Against Abbott in Thailand - a brief explanation of potential legal arguments, (March 23, 2007).
- Sean Flynn. Considering Competition Complaints Against Abbott - questions and answers regarding a complaint, (March 23, 2007)
- Sean Flynn. Analysis of Thai Law on Government Use Licenses, (December 18, 2006).
U.S. Government Documents
- Letter from U.S. Ambassador Ralph Boyce to General Surayud Chulanont. (July 20, 2007).
- Letter from 34 Members of Congress to U.S. Trade Representative Susan Schwab, (June 20, 2007).
- Office of the U.S. Trade Representative. Special 301 Report, (Exerpt on Thailand, 27) (April 30, 2007).
- Letter from five Sens. Lieberman, Menendez, Lautenberg, Carper, and Feinstein to the US Trade Representative Susan Schwab, (March 20, 2007).
- Letter from U.S. Trade Representative Susan Schwab to Rep. Tom Allen, (January 17, 2007).
- Letter from 22 Members of the U.S. Congress to U.S. Trade Representative Susan Schwab, (January 10, 2007).+
Thai Government Documents
- The 10 burning questions on the Government Use of Patents on the four anti-cancer drugs in Thailand, (February 20, 2008).
- National Health Security Office, Subcommittee for Benefits and Services Development. Accessibility to Medicines Under Compulsory Licenses: Anti-HIV/AIDS (Efavirenz, Kaletra) and Clopidogrel. (February 14, 2008).
- Competition Commission Finding. (December 27, 2007).
Thai Minister of Health Dr. Mongkol Na Songkhla. Reply to EC Commissioner Peter Madelson's July 18th Letter on Compulsory Licenses. (July, 2007). - Ministry of Health and the National Public Health Service. Facts and Evidences on the 10 Burning Issues Related to the Government Use of Patents on Three Pateneted Essential Drugs in Thailand, (February, 2007).
- Compulsory License for Lopinavir+Ritonavir (Kaletra). (January 29, 2007).
- Compulsory License for Clopidogrel (Plavix). (January 25, 2007).
- Compulsory License for Efavirenz (Sustiva). (November 29, 2006).
European Commission Documents
- Letter from Commissioner Peter Mandelson to Aides and Act Up-Paris. (September 3, 2007).
- Letter from Commissioner Peter Mandelson to Thai Minister of Commerce Krirk-krai Jirapaet. (July 10, 2007).
Civil Society Documents
- Oxfam, Affordagle Drug Policy Must Remain Intact. (June 11, 2008).
- Roger Bate, American Enterprise Institute. Drug Resistance Is Deadly. (June 10, 2008).
- Robert Weissman, Essential Action. USTR Action Against Thailand: Outrageous, Cynical, Shameful - Again. (April 25, 2008).
- Essential Action's Global Access to Medicines Bulletin. Thailand Lowers Medicine Prices, Faces US, EU Pressure. (April 14, 2008).
- Trans Atlantic Consumer Dialogue. Letter to USTR Susan Schwab and EC Commissioner for External Trade Peter Mandelson. (March 17, 2008).
- Essential Action. Data on Thai Compulsory License Benefits. (Mar. 12, 2008).
- Sarah Rimmington, Essential Action. EU confirms the legality of Thai generic medicines policy; denies threatening WTO litigation. (March 12, 2008).
- Virat Purahong, Chairperson of Thai Network of People Living with HIV/AIDS. Letter to the Editor of the Wall Street Journal Asia. (March 6, 2008).
- James Love, Knowledge Ecology International. Letter to Prime Minister Samak Sundaravej and Public Health Minister Chaiya Sasomsap. (March 4, 2008)
- Robert Weissman, Essential Action. Compulsory Licenses Are the Right Medicine, (February 23, 2008).
- US Civil Society Letter to Thai Minister of Public Health, (February 20, 2008).
- Letter to Thai Prime Minister and the Minister of Public Health from Nine Legal Experts, (February 19, 2008).
- ACT UP Paris and AIDES. European Commission's Pressure on Thailand: Mandelson Sacrifices Patients. (August 22, 2007).
- Essential Action. Comments on Waxman letter regarding USTR Pressure on Thailand for its Lawfully Issued Compulsory Licenses, (June 20, 2007).
- Joint Statement by 16 Thai Civil Society Groups. Thai Civil Society Supports the Health Ministers of Thailand and Brazil and Calls on Pharmaceutical Companies and lobbyists to Stop Abusing their Power. (May 10, 2007).
- Knowledge Ecology International. Statement on USTR 301 List Reference to Thailand, (April 30, 2007).
- Essential Action. USTR Action Against Thailand: Outrageous, Cynical, Shameful, (April 30, 2007).
- Sean Flynn, Professor Brook K. Baker (Health GAP and Northeastern U. School of Law), Judit Rius Sanjuan (Knowledge Ecology International). World's "Premiere" Law Firm Goes to Bat for Abbott: Specious Arguments on Thailand's Compulsory Licenses, (April 23, 2007).
- Brook Baker, Health GAP. Standing Up to Abbott's Decision to Withhold Registration and Marketing of Life-Saving Medicines - A New Variant of Phramaceutical Aparthied, (March 13, 2007).
- Knowledge Ecology International. Statement on Thailand's Compulsory Licenses, (January 25, 2007).
- Letter from Médecins Sans Frontières/Doctors Without Borders to the U.S. Trade Representative, (December 29, 2007).
- Sign-On letter from Civil Society to the U.S. Trade Representative, (December 21, 2007).
- Thai Network of People Living With HIV/AIDS Statement, (November 29, 2006).
World Health Organization Documents
Pharmaceutical Industry Documents
- 2008 PhRMA Submission to USTR for the Special 301 Report
- 2008 BIO Submission to USTR for the Special 301 Report
- Letter from Edward Kolly, Attorney for Sanofi-Synthelabo, to Suwit Chuririyagul and Sopon Manomaya from Bioscience Co. Ldt. (August 25, 2007).
- Letter from USA for Innovation to Members of Congress, (May 9, 2007).
- Op-ed by Lawyers for Baker & McKenzie, Which Represents Abbott, (April 23, 2007).
- Abbott Press Release Announcing the Price Cut, (April 10, 2007).
- Cipla Announcement of Generic, Heat - Stabilized Lopinavir+Ritonavir, (April, 2007).
